Clinical Trial Assessing Once Daily Raltegravir Administration (800 mg QD) in HIV-1-Infected Patients Receiving Unboosted Atazanavir (400 mg QD)- Based Antiretroviral Therapy

This study has been completed.
Sponsor:
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00718536
First received: July 16, 2008
Last updated: April 8, 2009
Last verified: April 2009

July 16, 2008
April 8, 2009
August 2008
January 2009   (final data collection date for primary outcome measure)
Raltegravir area under the curve (AUC) 24 hours and Cmin [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
Raltegravir AUC24h and Cmin [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00718536 on ClinicalTrials.gov Archive Site
  • Adverse events [ Time Frame: Baseline (BL), Day 10 ] [ Designated as safety issue: Yes ]
  • Adherence [ Time Frame: BL, Day 10 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: BL, Day 10 ] [ Designated as safety issue: Yes ]
  • Adherence [ Time Frame: BL, Day 10 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Clinical Trial Assessing Once Daily Raltegravir Administration (800 mg QD) in HIV-1-Infected Patients Receiving Unboosted Atazanavir (400 mg QD)- Based Antiretroviral Therapy
Clinical Trial Assessing Once Daily Raltegravir Administration (800 mg QD) in HIV-1-Infected Patients Receiving Unboosted Atazanavir (400 mg QD)- Based Antiretroviral Therapy

The co-administration of raltegravir with medicinal products that are knouwn to be potent UGT1A1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir. So once daily raltegravir (800 mg QD), instead of twice a day (400 mg BID), could be an appropriate therapeutic option in HIV-infected patients also receiving atazanavir-containing antiretroviral regimens. In this study, pharmacokinetic data supporting this hypothesis are recovered.

Treatment adherence is crucial for the effectiveness of antiretroviral therapy, and, in an attempt to promote treatment adherence by the patients, once daily (QD) regimens are preferred rather than twice daily (BID) regimens.

The dose of 400 mg BID of raltegravir has been recently licensed for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients.

Raltegravir is eliminated mainly by metabolism via uridine diphosphate glucuronyl transferase (UGT1A1)-mediated glucuronidation pathway. Thus, co-administration of raltegravir with medicinal products that are known to be potent UGT1A1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir.

Based on these data, it could be hypothesized that once daily raltegravir (800 mg QD) could be an appropriate therapeutic option in HIV-infected patients also receiving atazanavir-containing antiretroviral regimens. However, pharmacokinetic data supporting this hypothesis are lacking.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Addition of raltegravir 800 mg QD to HAART
Addition of raltegravir 800 mg QD to HAART
Other Name: HAART+RAL
Experimental: 1
Addition of raltegravir 800 mg QD to HAART
Intervention: Drug: Addition of raltegravir 800 mg QD to HAART
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients aged 18 to 65 years old with documented HIV-1 infection.
  2. Patients on antiretroviral regimen that includes atazanavir 400mg QD for at least 4 weeks.
  3. Complete virological suppression (<50 copies/mL) for at least 12 months.
  4. Voluntary written informed consent.
  5. Ability of compliance with visit schedule.

Exclusion Criteria:

  1. AIDS defining condition within 4 weeks prior to the initiation of the study.
  2. Concomitant treatment with ritonavir as well as with inducers (NNRTI, rifampin, carbamazepine, phenytoin, phenobarbital, valproic acid, etc) or inhibitors (probenecid, etc) of the uridine diphosphate glucuronyl transferase within 2 weeks before the screening visit.
  3. Concomitant therapy with tenofovir.
  4. History or suspected poor adherence to HAART.
  5. History of drug allergy to raltegravir
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00718536
RALqd-ATV
No
FUNDACIO LLUITA CONTRA LA SIDA, LLuita Sida Foundation
Germans Trias i Pujol Hospital
Not Provided
Principal Investigator: Clotet Bonaventura, MD,PhD Lluita contra la Sida Foundation, HIV Unit
Germans Trias i Pujol Hospital
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP